Senior Regulatory Affairs SpecialistLocation: Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required)
Company: VB Spine
What You'll Do:- Participate on cross-functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the earliest stages
- Author and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvals
- Communicate FDA and other Health Authority feedback/correspondence to project teams and RA leadership
- Support post-market submissions, including progress reports and annual reports
- Conduct regulatory assessments for proposed product changes, manufacturing changes, and product transfers
- Advise teams on appropriate regulatory pathways to market
- Interface and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issues
- Review and approve Engineering Change Notices (ECNs), labeling, collateral materials, and Instructions for Use (IFUs)
- Maintain regulatory information systems, US product listings, and CE Mark Technical Files / Design Dossiers
- Support internal and external audits and inspection readiness activities
- Contribute to the development and maintenance of Regulatory Affairs SOPs and processes
- Provide guidance and support to junior Regulatory Affairs Specialists and Associates
- Participate in continuous improvement initiatives within the Regulatory Affairs department
What You Bring:- Bachelor's degree (B.S. or B.A.) in a scientific area preferred; RAC certification desired
- Minimum 2+ years of experience in Regulatory Affairs within the FDA-regulated medical device industry
- Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation (required)
- Working knowledge of US and EU medical device regulations (international experience a plus)
- Strong interpersonal, written, and verbal communication skills
- Excellent organizational, planning, and project management abilities
- Ability to work effectively in a team environment and provide leadership on projects
- Proficiency with personal computer systems and desktop office applications
- Sound understanding of scientific and regulatory principles
Compensation:Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $100,000.00 - $105,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, regulatory expertise, and market conditions.
Benefits include:- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company
